Major Depressive DisorderNCT01740726
Comparison of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Depression
A study testing Behavioral Activation and Fluoxetine in people with Major Depressive Disorder, run by Emory University at 1 site in United States.
Trial summary
This study focuses on treating adolescents with depression. The study has two main purposes. The first is to compare a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Behavioral Activation and Fluoxetine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female adolescents ages 13-17
- Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating Scale (CDRS-R) raw score > 45 (T-score > 65) at baseline
- Estimated full scale IQ > 80 as determined by the Wechsler Intelligence Scale for Children (WISC)
- Able to receive outpatient care
- Willing to discontinue other psychosocial treatments
- Not taking psychotropic medications in the one month prior to consent, with the exception of psychostimulant medication prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD)
Who cannot join
- Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis not otherwise specified
- Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
- Taking psychotropic medications prior to entry
- Estimated IQ < 80
- Alcohol/drug dependence or abuse within the last 3 months
- Potential/confirmed neurological disorder or epilepsy
Show all 11Show fewer
- Claustrophobia
- Presence of a medical condition that precludes fMRI
- Endorsement of imminent and serious suicidality
- Medical conditions for which treatment with fluoxetine is contraindicated or that take precedence over the presence of major depressive disorder (MDD)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Major Depression
This study focuses on treating adolescents with depression. The study has two main purposes. The first is to compare a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more involved in activities they find enjoyable, which can reduce symptoms of depression. Research shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However, unlike previous research, this study examines how well the two treatment options work in comparison to each other. Participants in the study are randomized to receive treatment with either BA or fluoxetine for 18 weeks.
The second aim of the study is to examine the brain functions of adolescents in both treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans before and after treatment. The data from these scans will be used to compare the brains of participants in the BA condition with those in the fluoxetine condition. Also, the scans may show possible differences between participants' brains before and after treatment. These data may help scientists determine the ideal form of depression treatment for different types of people.
Read the detailed description
Depression is a serious diagnosis that can have severe consequences; it is not just experiencing "the blues" or having sad feelings that most people get from time to time. People who are diagnosed with depression have overwhelming feelings of sadness that are present for at least two weeks. In addition, they also experience symptoms such as changes in their appetite or sleep patterns, feelings of guilt or worthlessness, lack of energy or motivation, and even thoughts of suicide. People with depression have difficulty functioning in many areas of their lives, including at work, at school, and in social relationships. Those who have this diagnosis often need medication, therapy, or a combination of both to relieve their symptoms and regain their usual functioning.
This study investigates whether a type of psychotherapy called Behavioral Activation (BA) is as effective as antidepressant medication in the treatment of adolescents diagnosed with depression. In this study, BA is compared to fluoxetine, which is known to help treat depressive symptoms in this population. BA has been shown to be efficacious in reducing depression in adolescents, but it is not yet known how it compares to another leading treatment for depression in this age group. Thus, this study's primary goal is to see how BA compares to fluoxetine.
This study also examines brain activity as it relates to depression and treatment. The study includes functional Magnetic Resonance Imaging (fMRI) scans of participants in both conditions before and after they undergo treatment. Participants play a game in the scanner called the Monetary Incentive Delay (MID) task, and they have the opportunity to win money (reward) or to avoid losing money (loss). After they play the MID game, the scan images show certain brain regions that are activated in reward and loss situations. This study looks at how these brain regions relate to treatment response, especially because the goal of BA is to help people enjoy rewards more. The study also compares brain activity between the two treatment groups, as well as changes in brain activity from pre- to post-treatment. This part of the study should provide information about which kinds of people respond to which kinds of treatment.
Behavioral activation is a new therapy that has been shown to successfully treat depressed adults and adolescents. BA is a type of therapy that helps depressed people get involved in activities that they find to be enjoying and rewarding. The developers of this therapy believe that people are depressed because they are not experiencing rewarding and positive events in their lives very often. For example, when people become depressed, they usually become isolated from others. They also stop doing the things they used to enjoy, or they do them far less often. As a result, they have fewer experiences that make them feel a sense of accomplishment and happiness, and their depression becomes more severe. The worse the symptoms get, the less they engage in rewarding activities. The developers of BA have established a therapy program that helps the patient choose and participate in activities that are rewarding. The therapist acts as a coach, monitoring progress and giving feedback about these activities and the relationship between this activation and mood. This type of therapy is not just designed to get depressed people to do more; rather, time is spent choosing and evaluating specific activities that are particularly rewarding for the client and evaluating the outcome of these activities. Although BA is a novel intervention, early evidence shows that BA is effective with regard to alleviating symptoms of depression. In addition, the results of these studies show that it works in a relatively short amount of time (approximately four months).
Because so little is known about effective psychosocial treatments for depressed adolescents, and because of the risks associated with treating adolescents with medications, it is important to work on developing and supporting new treatments for this at-risk population. The aim of this pilot study is to generate knowledge for both the scientific community and for clinicians by gaining new insight into what works for depressed teens. To accomplish these goals, this study will treat 20 adolescents who meet criteria for Major Depressive Disorder with 18 weeks of therapy or medication. Ten adolescents will be assigned to the BA condition, and 10 will be assigned to the fluoxetine condition. Those in the medication condition will visit with their psychiatrist regularly but will not receive psychotherapy. Those who receive BA will receive between 18 and 20 sessions of therapy.
It is important to note that people are experiencing first episodes of depression at younger and younger ages; hence, rates of depression are rising in younger age groups. Also, suicide is the third leading cause of death among adolescents, and depression is associated with increased thoughts of suicide and suicide attempts. Depressed children and adolescents are more likely to develop a host of other problems, such as substance abuse, and they are more likely to report experiencing stressful life events. For all these reasons, it is important that scientists work to develop therapies that relieve depression in this population. Studies such as this one can help advance knowledge about how best to treat this dangerous illness.
- Conditions
- Major Depressive Disorder
- Being tested
- Behavioral Activation, Fluoxetine
- Keywords
- Depression, Behavioral Activation, Fluoxetine, Prozac, Treatment, Therapy, Psychotherapy, Antidepressant, Intervention
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Also called Behavioral Activation Therapy, BA
18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
FluoxetineDrug
Also called Prozac, Sarafem, Rapiflux, Selfemra
Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | Not described Receives: Behavioral: Behavioral Activation |
| Fluoxetine | Active comparator | Not described Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)
Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.
Measured: Baseline, 42 weeks
Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)
Interview-based measure, completed with both the parent and child, that assesses depression severity.
Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Secondary outcomes (5)
Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)
Clinician's rating of symptom severity and improvement since baseline.
Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)
Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.
Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)
Measures anxiety symptom severity.
Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)
Assesses seriousness of suicidal intent.
Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Hope Based on Children's Hope Scale (CHS)
Assesses self-perception of ability to set and work toward goals.
Measured: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Lack of success with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Edward Craighead, Emory University
- Investigators
- Edward Craighead, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740726
- Sponsor's protocol ID
- IRB00061525
- Other IDs
- CAMP-61525
- Status last verified
- Mar 2015
- First submitted
- 28 Nov 2012
- Last updated
- 20 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ritschel, L. A., Ramirez, C. L., Jones, M., & Craighead, W. (2011). Behavioral activation for depressed teens: A pilot study. Cognitive And Behavioral Practice, 18(2), 281-299. doi:10.1016/j.cbpra.2010.07.002
Jacob M, Keeley ML, Ritschel L, Craighead WE. Behavioural activation for the treatment of low-income, African American adolescents with major depressive disorder: a case series. Clin Psychol Psychother. 2013 Jan-Feb;20(1):87-96. doi: 10.1002/cpp.774. Epub 2011 Aug 22.
PubMed 21861272
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Major Depression
- ClinicalTrials.gov ID
- NCT01740726
- Acronym / sponsor ID
- IRB00061525
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Behavioral Activation, Fluoxetine, Prozac, Treatment, Therapy, Psychotherapy, Antidepressant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of success with recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 7 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on treating adolescents with depression. The study has two main purposes. The first is to compare a new form of therapy for depression called Behavioral Activation (BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more involved in activities they find enjoyable, which can reduce symptoms of depression. Research shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However, unlike previous research, this study examines how well the two treatment options work in comparison to each other. Participants in the study are randomized to receive treatment with either BA or fluoxetine for 18 weeks.
The second aim of the study is to examine the brain functions of adolescents in both treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans before and after treatment. The data from these scans will be used to compare the brains of participants in the BA condition with those in the fluoxetine condition. Also, the scans may show possible differences between participants' brains before and after treatment. These data may help scientists determine the ideal form of depression treatment for different types of people.
Detailed description
Depression is a serious diagnosis that can have severe consequences; it is not just experiencing "the blues" or having sad feelings that most people get from time to time. People who are diagnosed with depression have overwhelming feelings of sadness that are present for at least two weeks. In addition, they also experience symptoms such as changes in their appetite or sleep patterns, feelings of guilt or worthlessness, lack of energy or motivation, and even thoughts of suicide. People with depression have difficulty functioning in many areas of their lives, including at work, at school, and in social relationships. Those who have this diagnosis often need medication, therapy, or a combination of both to relieve their symptoms and regain their usual functioning.
This study investigates whether a type of psychotherapy called Behavioral Activation (BA) is as effective as antidepressant medication in the treatment of adolescents diagnosed with depression. In this study, BA is compared to fluoxetine, which is known to help treat depressive symptoms in this population. BA has been shown to be efficacious in reducing depression in adolescents, but it is not yet known how it compares to another leading treatment for depression in this age group. Thus, this study's primary goal is to see how BA compares to fluoxetine.
This study also examines brain activity as it relates to depression and treatment. The study includes functional Magnetic Resonance Imaging (fMRI) scans of participants in both conditions before and after they undergo treatment. Participants play a game in the scanner called the Monetary Incentive Delay (MID) task, and they have the opportunity to win money (reward) or to avoid losing money (loss). After they play the MID game, the scan images show certain brain regions that are activated in reward and loss situations. This study looks at how these brain regions relate to treatment response, especially because the goal of BA is to help people enjoy rewards more. The study also compares brain activity between the two treatment groups, as well as changes in brain activity from pre- to post-treatment. This part of the study should provide information about which kinds of people respond to which kinds of treatment.
Behavioral activation is a new therapy that has been shown to successfully treat depressed adults and adolescents. BA is a type of therapy that helps depressed people get involved in activities that they find to be enjoying and rewarding. The developers of this therapy believe that people are depressed because they are not experiencing rewarding and positive events in their lives very often. For example, when people become depressed, they usually become isolated from others. They also stop doing the things they used to enjoy, or they do them far less often. As a result, they have fewer experiences that make them feel a sense of accomplishment and happiness, and their depression becomes more severe. The worse the symptoms get, the less they engage in rewarding activities. The developers of BA have established a therapy program that helps the patient choose and participate in activities that are rewarding. The therapist acts as a coach, monitoring progress and giving feedback about these activities and the relationship between this activation and mood. This type of therapy is not just designed to get depressed people to do more; rather, time is spent choosing and evaluating specific activities that are particularly rewarding for the client and evaluating the outcome of these activities. Although BA is a novel intervention, early evidence shows that BA is effective with regard to alleviating symptoms of depression. In addition, the results of these studies show that it works in a relatively short amount of time (approximately four months).
Because so little is known about effective psychosocial treatments for depressed adolescents, and because of the risks associated with treating adolescents with medications, it is important to work on developing and supporting new treatments for this at-risk population. The aim of this pilot study is to generate knowledge for both the scientific community and for clinicians by gaining new insight into what works for depressed teens. To accomplish these goals, this study will treat 20 adolescents who meet criteria for Major Depressive Disorder with 18 weeks of therapy or medication. Ten adolescents will be assigned to the BA condition, and 10 will be assigned to the fluoxetine condition. Those in the medication condition will visit with their psychiatrist regularly but will not receive psychotherapy. Those who receive BA will receive between 18 and 20 sessions of therapy.
It is important to note that people are experiencing first episodes of depression at younger and younger ages; hence, rates of depression are rising in younger age groups. Also, suicide is the third leading cause of death among adolescents, and depression is associated with increased thoughts of suicide and suicide attempts. Depressed children and adolescents are more likely to develop a host of other problems, such as substance abuse, and they are more likely to report experiencing stressful life events. For all these reasons, it is important that scientists work to develop therapies that relieve depression in this population. Studies such as this one can help advance knowledge about how best to treat this dangerous illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral Activation |
| Fluoxetine | Active comparator | Drug: Fluoxetine |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female adolescents ages 13-17
- Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating Scale (CDRS-R) raw score > 45 (T-score > 65) at baseline
- Estimated full scale IQ > 80 as determined by the Wechsler Intelligence Scale for Children (WISC)
- Able to receive outpatient care
- Willing to discontinue other psychosocial treatments
Key exclusion criteria (11 listed)
- Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis not otherwise specified
- Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
- Taking psychotropic medications prior to entry
- Estimated IQ < 80
- Alcohol/drug dependence or abuse within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral ActivationAlso: Behavioral Activation Therapy, BA18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up. | Behavioural | Behavioral Activation |
| FluoxetineAlso: Prozac, Sarafem, Rapiflux, SelfemraInitial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies. | Drug | Fluoxetine |
Primary outcome
Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)
Time frame: Baseline, 42 weeks
Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.
Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)
Time frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Interview-based measure, completed with both the parent and child, that assesses depression severity.
5 secondary outcomes
Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)
Time frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)
Time frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)
Time frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)
Time frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Change in Hope Based on Children's Hope Scale (CHS)
Time frame: Baseline, 9 wks., 18 wks., 30 wks., 42 wks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundRitschel, L. A., Ramirez, C. L., Jones, M., & Craighead, W. (2011). Behavioral activation for depressed teens: A pilot study. Cognitive And Behavioral Practice, 18(2), 281-299. doi:10.1016/j.cbpra.2010.07.002
- Background: PubMed 21861272Jacob M, Keeley ML, Ritschel L, Craighead WE. Behavioural activation for the treatment of low-income, African American adolescents with major depressive disorder: a case series. Clin Psychol Psychother. 2013 Jan-Feb;20(1):87-96. doi: 10.1002/cpp.774. Epub 2011 Aug 22.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Craighead, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Fluoxetine in people with Major Depressive Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II) (time frame: Baseline, 42 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.